The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

The PROACT LUNG Study: A Prospective Observational Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening

Date Added
December 11th, 2023
PRO Number
Pro00132779
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer/Lung, Lung
Summary

This study seeks to enroll patients in who are going to be getting a Low Dose CT scan as a part of Lung Cancer Screening and collect a blood sample that will be used to help to further develop and validate the Freenome FMBT-Lung test.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

CORD clamping among neonates with Congenital Heart Disease

Date Added
December 11th, 2023
PRO Number
Pro00131976
Researcher
Sinai Zyblewski

List of Studies


Keywords
Heart, Pediatrics, Pregnancy
Summary

A randomized clinical trial study that compares 2 different timepoints to clamp the cord at birth. The study involves babies with heart disease born between 37 0/7- 41 6/7 weeks of pregnancy. Doctors will clamp the umbilical cord around 30 seconds (between 1-<60 seconds) after birth vs. around 120 seconds (between 60-<180 seconds) after birth. Doctors consider both treatment groups to be "usual care." A goal of this study is to find out which umbilical cord clamping timepoint is best for babies with heart disease.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-901-4153
alsarral@musc.edu

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge

Date Added
December 5th, 2023
PRO Number
Pro00131771
Researcher
Haley Burdge

List of Studies

Keywords
Breastfeeding
Summary

This study aims to improve the breastfeeding skills of premature or sick term infants with non-invasive, transcutaneous vagus nerve stimulation (taVNS). taVNS is microcurrent stimulation to the ear, which targets a vagus nerve branch. Pairing taVNS with motor activity, such as breast feeding, may help with motor learning in infants as it does in adults with stroke. Ten premature infants older than or equal to 35 weeks gestational age, or convalescing sick term infants whose mothers want to breastfeed will participate in this study with parental consent. Infants will receive 1 taVNS treatment paired with breastfeeding per day for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort. This level of electrical stimulation will be delivered by a TENS unit (Transcutaneous elecrical nerve stimulation) and neonatal electrodes applied just in front of the ear and our custom made carbon electrode used in the BabyStrong studies (#10881, #67997). Stimulation will be timed with latching and sucking for the duration of the feed and will be on with sucking and off with rest. Pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow efficiency will be recorded. Parental satisfaction will be assessed by questionnaires at the beginning, after 1 and 2 weeks, and 3 months after the end of treatment to assess infants' progress in and maintenance of breastfeeding abilities.
If pairing breastfeeding with taVNS is able to improve effective breastfeeding in infants in the neonatal intensive care units, it might help premature and sick term infants to successfully breastfeed at the time of discharge and maintain breast feeding at home after discharge. Premature infants may benefit from longer time receiving maternal breastmilk.

Institution
MUSC
Recruitment Contact
Haley Burdge
843-214-4089
burdge@musc.edu

A randomized, sham-controLled, clinical Trial For evaLuation Of the EdWards APTURE transcatheter shunt system (ALT-FLOW II)

Date Added
November 28th, 2023
PRO Number
Pro00132875
Researcher
Brian Houston

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This is a study to evalaute the device's safety, function, and effects on heart function, and clinical outcomes of using the Edwards APTURE system (study device) in subjects with heart failure.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF EFZOFITIMOD IN PATIENTS WITH SYSTEMIC SCLEROSIS RELATED INTERSTITIAL LUNG DISEASE

Date Added
November 27th, 2023
PRO Number
Pro00131869
Researcher
Richard Silver

List of Studies


Keywords
Drug Studies, Scleroderma
Summary

The purpose of this study is to test whether a drug called efzofitimod (the study drug) is a potential treatment for patients with Systemic Sclerosis associated with Interstitial Lung Disease (SSc-ILD).

Efzofitimod is an investigational drug that is given by infusion every 4 weeks for a total of 6 doses. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, efzofitimod will be compared with a placebo (dummy drug). The placebo will be a saline solution that does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of efzofitimod or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know what you are receiving, the study efzofitimod or placebo.

The study is sponsored by aTyr Pharma, Inc. Participation in the study will require 9 visits to the MUSC main campus and will have the following procedures completed over the course of your participation: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as asked to complete surveys.

Compensation is available for participation

Institution
MUSC
Recruitment Contact
Miranda Irvin
843-792-8613
scledodermaresearch@musc.edu



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